BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSURETHRAL CATHETER

    MDR report key: 4929266 · Received July 21, 2015

    Report

    Report Number
    8040412-2015-00153
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED. UNDER VISUAL EXAMINATION, NO DESIGN ABNORMALITY OR MATERIAL DEGRADATION WERE OBSERVED ON THE CATHETER. HOWEVER A TEAR WAS OBSERVED AT DRAINAGE FUNNEL. BASED ON ADDITIONAL INFORMATION, THE FAILURE OCCURRED AFTER 3 DAYS OF USAGE. THIS INDICATED THAT THE PRODUCT WAS ABLE TO PERFORM WELL AT THE BEGINNING. THERE ARE VARIOUS REASONS WHICH COULD HAVE LIKELY CONTRIBUTED TOWARDS TORN OR BROKEN, FUNNEL. IN CURRENT STANDARD OPERATING PROCEDURE, 100% VISUAL INSPECTION IS CONDUCTED ON THE CATHETER AND PRODUCT IS RELEASED UPON PASSING THIS INSPECTION. BASED ON THE INVESTIGATION CONDUCTED, THERE ARE VARIOUS REASONS THAT COULD CAUSE THE FUNNEL TO BE TORN AND IN CURRENT MANUFACTURING PROCESS 100% VISUAL INSPECTION IS CONDUCTED WHEREBY DEFECTIVE PRODUCT WILL BE CULLED OUT. THEREFORE WE ARE NOT ABLE TO CONFIRM THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT.THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE FUNNEL WAS TORN AFTER A FEW DAYS. CATHETER WAS REPLACED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE FUNNEL WAS TORN AFTER A FEW DAYS. CATHETER WAS REPLACED.THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472699 TRANSURETHRAL CATHETER FOLEY CATHETER FGH TELEFLEX MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1